UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038517 |
|---|---|
| Receipt number | R000043893 |
| Scientific Title | A study on the relationship between remnant stomach volume and postoperative QOL |
| Date of disclosure of the study information | 2019/11/08 |
| Last modified on | 2019/11/07 23:34:48 |
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Basic information
Public title
A study on the relationship between remnant stomach volume and postoperative QOL
Acronym
A study on the relationship between remnant stomach volume and postoperative QOL
Scientific Title
A study on the relationship between remnant stomach volume and postoperative QOL
Scientific Title:Acronym
A study on the relationship between remnant stomach volume and postoperative QOL
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between remnant stomach volume and postgastrectomy syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship of PGSAS-37 and remnant stomach volume
Key secondary outcomes
The relationship of body composition change and remnant stomach volume
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intravenously infuse butylscopolamine 1A (10 mg). Patients with glaucoma, benign prostatic hyperplasia use glucagon (not for patients with diabetes).
After taking 6 g of foaming agent with 10 ml of water, CT examination is performed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gastrectomy for gastric cancer since 2010
No recurrence for more than 1 year after surgery
Has not developed a malignant tumor within the past 5 years (excluding intramucosal cancer)
Consent is obtained in writing
Gastric resection is scheduled at this hospital
Key exclusion criteria
Taking postoperative adjuvant therapy or taking medication for side effects of postoperative adjuvant therapy
Comorbidities of poor control (including insulin use and oral steroids)
Cases judged by the attending physician as ineligible
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka Medical College
Division name
Department of General and Gastroenterological Surgery
Zip code
569-8686
Address
2-7 daigaku-machi Takatsuki city, Osaka
TEL
072-683-1221
sur148@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka Medical College
Division name
Department of General and Gastroenterological Surgery
Zip code
569-8686
Address
2-7 daigaku-machi Takatsuki city, Osaka
TEL
072-683-1221
Homepage URL
sur148@osaka-med.ac.jp
Sponsor or person
Institute
Department of General and Gastroenterological Surgery,
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of General and Gastroenterological Surgery,
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College
Address
2-7 daigaku-machi Takatsuki city, Osaka
Tel
072-683-1221
sur148@osaka-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪医科大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 07 | Day |
Last modified on
| 2019 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043893
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
